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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. DUODERM CGF DRS 10X10CM; DRESSING,WOUND,OCCLUSIVE
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CONVATEC, INC. DUODERM CGF DRS 10X10CM; DRESSING,WOUND,OCCLUSIVE Back to Search Results
Model Number 187660
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Reporting duoderm dressing releasing from skin.
 
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Brand Name
DUODERM CGF DRS 10X10CM
Type of Device
DRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
CONVATEC, INC.
211 american ave
greensboro NC 27409
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5116916
MDR Text Key27217094
Report Number1049092-2015-30063
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date11/30/2017
Device Model Number187660
Device Lot Number2L01400
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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